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FDA 510(k)

Pleurx Pleural Catheter System

K-Number: K160450 · 2016-10-31

ApplicantCare Fusion
Decision Date2016-10-31
Product CodeDWM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pleurx Pleural Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2016-10-31 under 510(k) number K160450. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pleurx Pleural Catheter System?

Pleurx Pleural Catheter System is a medical device that received FDA 510(k) clearance on 2016-10-31. The listed applicant is Care Fusion. The 510(k) number is K160450.

When did Pleurx Pleural Catheter System receive FDA 510(k) clearance?

Pleurx Pleural Catheter System received FDA 510(k) clearance on 2016-10-31, under 510(k) number K160450.

Who is the listed applicant for Pleurx Pleural Catheter System?

The FDA 510(k) record lists Care Fusion as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pleurx Pleural Catheter System?

The FDA product code for Pleurx Pleural Catheter System is DWM.

Other records listing Care Fusion as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212696Aspira Pleural Drainage SystemMerit Medical Systems, Inc.K210509Rocket Platinum Cured CathterRocket Medical PlcK201404Passio Pump Drainage SystemBearpac MedicalK190292Passio Pump Drainage SystemBearpac MedicalK163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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